MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY PLUS RX STENT SYSTEM; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	M00547540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted to treat an duct in the dilation during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.Reportedly, a ct scan performed sometime after the implant procedure, revealed the stent was not found, it migrated from the implant zone.Another ercp procedure was performed which confirmed the stent was not in the patient and another stent was implanted.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0104002 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.

• Brand Name: WALLFLEX BILIARY PLUS RX STENT SYSTEM
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24138068
• Report Number: 3005099803-2026-00275
• Device Sequence Number: 17507100
• Product Code: FGE
• UDI-Device Identifier: 00191506044527
• UDI-Public: (01)00191506044527
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K242950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00547540
• Device Catalogue Number: M00547540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 01/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown